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CompletedNCT03293433miR-NodUpdated Jul 16, 2019

Quantification of microRNAs in Diagnosis of Pulmonary Nodules

An observational study in Pulmonary Cancer, sponsored by University Hospital, Toulouse. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
103
Ages
18 Years and older
Sex
All
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Study summary

One of the main challenges of thoracic oncology lies in earlier diagnosis of lung cancer to improve survival rate, wich is about 15% at 5 years. This poor prognosis is often linked to late diagnosis. Efforts are being made worldwide to offer testing in patients at risk or earlier diagnosis of lung cancer in order to offer the patient curative treatments. Indeed, supported at the stage of nodule (less than 3 cm lesion), lung cancer is curable by surgery in 80% of patients. Nevertheless, there are many differential diagnoses and access to these lesions is often difficult and risky. In this context, the management of pulmonary nodules, which can be either benign lesions or beginners cancers, is a real challenge for pulmonologists and thoracic oncologists every day: it is important not to disregard a potentially operable nodule and avoiding offer patients invasive procedures for benign nodules. Indeed, many procedures (endoscopy, puncture under scanner, thoracotomy) are made to determine if suspicious nodules are benign or not. In the large National Lung Screening Trial, 28% of the procedures were associated with complications (including 11% classified severe and 16 deaths). It is therefore essential to develop non-invasive tools to refine treatment decisions.

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Conditions studied

  • Pulmonary Cancer

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In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 103 is below the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.

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Lead sponsor

University Hospital, Toulouse is the lead sponsor of 805 studies on the registry; 215 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with pulmonary nodule showed in scanner (defined as a rounded picture higher than 5 mm and less than 30 mm in the lung parenchyma) presenting at one of the 3 participant services and meeting the inclusion criteria and exclusion.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with suspected abnormal chest X-ray image of malignancy defined by one solitary pulmonary nodule (NPS) NPS or 2 if operable, higher than 5 mm and less to 30 mm, without histological evidence.
  • Affiliation to social security.
  • Signature of informed consent.

Exclusion criteria

Exclusion Criteria:

  • Nodule not accessible to curative local therapy (surgery, thermoablation, radiotherapy).
  • Patients in whom resection for diagnostic purposes this emergency such as one of these characters can not be delayed (these patients are not likely to belong to the people that can take a dosage of clinical interest miRNAs because the characteristics radiographic their nodule only tell them a high probability of lung cancer)
  • History of an unhealed cancer
  • Patients benefiting from a system of legal protection
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patient with lung cancer

    Patient with pulmonary nodule showed in scanner (defined as a rounded picture higher than 5 mm and less than 30 mm in the lung parenchyma) presenting at one of the 3 participant services and meeting the inclusion criteria and exclusion. A blood punction will be performed in order to extract micro RNA.

    Other: Blood punction

Interventions

  • OtherBlood punction

    1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of micro RNA.

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What researchers measure

Primary outcomes

  1. 34 micro RNA extraction as assessed by quantification of micro RNA with Real-Time Quantitative Reverse Transcription polymerase chain reaction

    Time frame: Through the completion of study (18 months)

Secondary outcomes

  1. Measure the inter-observer reproducibility as assessed by quantification of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction

    Time frame: Through the completion of study (18 months)

  2. Measure the inter-laboratory reproducibility as assessed by rate of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction

    Time frame: Through the completion of study (18 months)

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Study locations

2 sites
  • University Hospital of la Réunion
    La Réunion, 97400, France
  • University Hospital of Toulouse
    Toulouse, 31059, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03293433
Responsible party
Sponsor
First posted
Sep 26, 2017
Start date
Nov 2015
Primary completion
May 2018
Completion
May 2019
Last update
Jul 16, 2019

Study contacts

GUIBERT NICOLAS, MD
principal investigator · University Hospital of Toulouse

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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